Sexual HealthNCT07912918
the Effect of Exercise on Sexual Function and Quality of Life in Postpartum Women
A study testing Resistance Exercise in people with Sexual Health and Quality of Life, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
The goal of this clinical trial is to learn if resistance exercise works to promote sexual health or quality of life in postpartum women. The main questions it aims to answer are: Can a set of physical exercises lead to an improvement in women's perception of their quality of life or their sexual function during the… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Health, Quality of Life, Postpartum Women
- What is being tested?
- Resistance Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteIran
- Study dates
- 19 Jan 2025to 21 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Having a willingness to participate in the study
- Iranian nationality and residence in Isfahan
- Living with spouse and resuming sexual activity after childbirth
- Primiparous (normal vaginal delivery) and a lapse of two months since delivery
- Delivery at term (more than 37 weeks) and a healthy infant
- Reading and writing literacy
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- Exclusive breastfeeding
- Willingness to engage in physical exercise, the motor ability required to perform the exercises, and the absence of motor disabilities (It is examined in person by the researcher)
- Normal Body Mass Index: BMI (19.8-26 kg/m²)
- The mother is on maternity leave (returning to work-particularly in arduous or physically demanding jobs-could influence the study variables
Who cannot join
- History of underlying medical conditions (confirmed by a physician or documented in the electronic health record)
- History of severe mental illness requiring hospitalization during pregnancy or the postpartum period
- Disabilities and structural and mobility issues
- Below-normal sexual function (scoring less than 28 on FSFI)
- Active sore or lesion in the genital area (which was examined by the researcher if its presence was suspected)
- Presence of uterine prolapse, cystocele, and grade 4 rectocele-conditions the patient complained of and which were confirmed by the researcher through visual inspection during the examination
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- Drug and alcohol use (recreational or chronic)
- Use of medications affecting sexual function
- Maintaining an active lifestyle or engaging in sports-whether professionally or regularly-during the preconception, pregnancy, or postpartum periods, such that it becomes part of their daily routine
- Pregnancy-related changes that have not yet returned to the pre-pregnancy state, such as preeclampsia, gestational diabetes, and gestational hypertension
- If the mother suffered from severe joint pain that hindered her ability to perform daily activities, she was excluded from the study, in addition to being referred to the appropriate specialists for treatment and management of her condition
- Difficult delivery (using vacuum and forceps) or third- or fourth-degree perineal tear
Trial locations and contacts
1 site in 1 country.
Iran1 site
Shahid Navab Safavi Comprehensive Health Service Center in Isfahan
Isfahan, Isfahan
About this study
Official title: Investigating the Effect of Resistance Exercise on Sexual Function and Quality of Life in Postpartum Women
The goal of this clinical trial is to learn if resistance exercise works to promote sexual health or quality of life in postpartum women. The main questions it aims to answer are:
Can a set of physical exercises lead to an improvement in women's perception of their quality of life or their sexual function during the postpartum period? Researchers are comparing the effect of these exercises with routine postpartum care.
Participants will:
Mothers who are two months postpartum (following a vaginal delivery), provided they meet specific criteria-such as having a healthy infant and exclusive breastfeeding.
- Conditions
- Sexual Health, Quality of Life, Postpartum Women
- Being tested
- Resistance Exercise
- Keywords
- Quality of life, sexual health, Postpartum Period
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance ExerciseOther
At the intervention centers, a suitable location was designated for instruction on how to perform the exercises during the first four weeks. To ensure privacy, participants received individual, face-to-face training from the researcher and practiced the exercise program once under the researcher's supervision during the first session. At the end of the fourth week of the intervention, participants received individual, face-to-face instruction on how to perform the exercises for the subsequent four weeks.The program consisted of three exercise sessions per week, with each session lasting 50 minutes. Each session included a general warm-up emphasizing the muscle groups involved in that session (5-10 minutes), six resistance exercises (35 minutes), and a cool-down period (5 minutes). The exercises remained the same over each two-week period; however, the number of sets and repetitions increased in the second week.
| Study group | Role | What they receive |
|---|---|---|
| Control group (routine postnatal care) | No intervention | Control |
| Resistance Exercise | Experimental | Not described Receives: Other: Resistance Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Mean score of Female Sexual function index at 8 weeks
The Female Sexual Function Index (FSFI) was first developed and validated by Rosen in 2000 . It consists of 19 items that assess sexual function across six domains over the past four weeks: desire (items 1 and 2), sexual arousal (items 3-6), lubrication (items 7-10), orgasm (items 11-13), pain (items 14-16), and sexual satisfaction (items 17-19).
A score of 0 indicates that the individual has not engaged in sexual activity during the past four weeks. The total score for the questionnaire is obtained by summing the scores from all six domains; a higher score indicates better sexual function .
Measured: Before the intervention begins and after it concludes-which is at the end of the 8th week following the start of the intervention-this questionnaire is completed by participants in both groups as a self-report measure.
Change from Baseline in the Mean score of Short Form Health Survey (SF-36) at 8 weeks.
The overall score ranges from 0 to 100, where 0 represents the worst state and 100 represents the best.This self-report questionnaire, primarily used to assess quality of life and health, was developed by Ware and Sherbourne. It consists of 36 items and evaluates eight domains: physical functioning, social functioning, role limitations due to physical health, role limitations due to emotional problems, mental health, vitality, bodily pain, and general health. Furthermore, the SF-36 provides two summary measures of functioning: the Physical Component Summary (PCS) score, which assesses the physical dimension of health, and the Mental Component Summary (MCS) score, which evaluates the psychosocial dimension of health.
Measured: Before the intervention begins and after it concludes-which is at the end of the 8th week following the start of the intervention-this questionnaire is completed by participants in both groups as a self-report measure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start19 Jan 2025
- Primary completion21 Nov 2025
- Study completion21 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kobra Salehi, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912918
- Sponsor's protocol ID
- 3403132
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: only Study Protocol, Informed Consent Form (ICF), Clinical Study Report (CSR) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of Resistance Exercise on Sexual Function and Quality of Life in Postpartum Women
- ClinicalTrials.gov ID
- NCT07912918
- Acronym / sponsor ID
- 3403132
- Conditions
- Sexual Health, Quality of Life, Postpartum Women
- Keywords
- Quality of life, sexual health, Postpartum Period
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- 19 Jan 2025 (actual)
- Primary completion
- 21 Nov 2025 (actual)
- Study completion
- 21 Nov 2025 (actual)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if resistance exercise works to promote sexual health or quality of life in postpartum women. The main questions it aims to answer are:
Can a set of physical exercises lead to an improvement in women's perception of their quality of life or their sexual function during the postpartum period? Researchers are comparing the effect of these exercises with routine postpartum care.
Participants will:
Mothers who are two months postpartum (following a vaginal delivery), provided they meet specific criteria-such as having a healthy infant and exclusive breastfeeding.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (routine postnatal care) | No intervention | –Control |
| Resistance Exercise | Experimental | Other: Resistance Exercise |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Having a willingness to participate in the study
- Iranian nationality and residence in Isfahan
- Living with spouse and resuming sexual activity after childbirth
- Primiparous (normal vaginal delivery) and a lapse of two months since delivery
- Delivery at term (more than 37 weeks) and a healthy infant
Key exclusion criteria (12 listed)
- History of underlying medical conditions (confirmed by a physician or documented in the electronic health record)
- History of severe mental illness requiring hospitalization during pregnancy or the postpartum period
- Disabilities and structural and mobility issues
- Below-normal sexual function (scoring less than 28 on FSFI)
- Active sore or lesion in the genital area (which was examined by the researcher if its presence was suspected)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance ExerciseAt the intervention centers, a suitable location was designated for instruction on how to perform the exercises during the first four weeks. To ensure privacy, participants received individual, face-to-face training from the researcher and practiced the exercise program once under the researcher's supervision during the first session. At the end of the fourth week of the intervention, participants received individual, face-to-face instruction on how to perform the exercises for the subsequent four weeks.The program consisted of three exercise sessions per week, with each session lasting 50 minutes. Each session included a general warm-up emphasizing the muscle groups involved in that session (5-10 minutes), six resistance exercises (35 minutes), and a cool-down period (5 minutes). The exercises remained the same over each two-week period; however, the number of sets and repetitions increased in the second week. | Other | Resistance Exercise |
Primary outcome
Change from Baseline in the Mean score of Female Sexual function index at 8 weeks
Time frame: Before the intervention begins and after it concludes-which is at the end of the 8th week following the start of the intervention-this questionnaire is completed by participants in both groups as a self-report measure.
The Female Sexual Function Index (FSFI) was first developed and validated by Rosen in 2000 . It consists of 19 items that assess sexual function across six domains over the past four weeks: desire (items 1 and 2), sexual arousal (items 3-6), lubrication (items 7-10), orgasm (items 11-13), pain (items 14-16), and sexual satisfaction (items 17-19). A score of 0 indicates that the individual has not engaged in sexual activity during the past four weeks. The total score for the questionnaire is obtained by summing the scores from all six domains; a higher score indicates better sexual function .
Change from Baseline in the Mean score of Short Form Health Survey (SF-36) at 8 weeks.
Time frame: Before the intervention begins and after it concludes-which is at the end of the 8th week following the start of the intervention-this questionnaire is completed by participants in both groups as a self-report measure.
The overall score ranges from 0 to 100, where 0 represents the worst state and 100 represents the best.This self-report questionnaire, primarily used to assess quality of life and health, was developed by Ware and Sherbourne. It consists of 36 items and evaluates eight domains: physical functioning, social functioning, role limitations due to physical health, role limitations due to emotional problems, mental health, vitality, bodily pain, and general health. Furthermore, the SF-36 provides two summary measures of functioning: the Physical Component Summary (PCS) score, which assesses the physical dimension of health, and the Mental Component Summary (MCS) score, which evaluates the psychosocial dimension of health.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes. only Study Protocol, Informed Consent Form (ICF), Clinical Study Report (CSR) will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Exercise in people with Sexual Health and Quality of Life, run by Isfahan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Mean score of Female Sexual function index at 8 weeks (time frame: Before the intervention begins and after it concludes-which is at the end of the 8th week following the start of the intervention-this questionnaire is completed by participants in both groups as a self-report measure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.